Manager of Regulatory Affairs Jobs in Westford, MA
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Executive Director, Regulatory Affairs
- Dyne Therapeutics, Inc.
- Waltham, MA (16 miles from Westford, MA)
- 6 days ago
- Waltham, MA (16 miles from Westford, MA)
- 6 days ago
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target...
In PersonDirect Hire SR Manager Regulatory Affairs
- Adecco
- Andover, MA (14 miles from Westford, MA)
- 11 days ago
- Andover, MA (14 miles from Westford, MA)
- 11 days ago
Direct Hire SR Manager Regulatory Affairs Adecco - 3.7 Andover, MA Job Details $128,000 - $145,000 a year 8 hours ago Benefits Health insurance Dental insurance Paid time off 401(k) 4% Match Vision...
In Person- ThermoFisher Scientific
- Waltham, MA (16 miles from Westford, MA)
- 11 days ago
- Waltham, MA (16 miles from Westford, MA)
- 11 days ago
management systems Advanced project management and organizational skills Excellent verbal and written communication abilities Effective negotiation and influencing skills Ability to work effectively...
In Person- Deciphera Pharmaceuticals
- Waltham, MA (16 miles from Westford, MA)
- 12 days ago
- Waltham, MA (16 miles from Westford, MA)
- 12 days ago
Manager, Regulatory Affairs Deciphera Pharmaceuticals - 5.0 Waltham, MA Job Details Full-time $116,000 - $160,000 a year 2 hours ago Benefits Health insurance Dental insurance Parental leave Vision...
In PersonSr. Director, Regulatory Affairs
- Akebia Therapeutics
- Cambridge, MA (21 miles from Westford, MA)
- 13 days ago
- Cambridge, MA (21 miles from Westford, MA)
- 13 days ago
Sr. Director, Regulatory Affairs LinkedIn Twitter Email Message Share Regulatory Affairs Remote * ID: 25R-27 * Full-Time/Regular This position is currently based in our Cambridge, MA office....
In Person- Bausch + Lomb
- Natick, MA (21 miles from Westford, MA)
- 24 days ago
- Natick, MA (21 miles from Westford, MA)
- 24 days ago
Jobs Natick, MA Director, Regulatory Affairs Bausch + Lomb Director, Regulatory Affairs Natick, MA Apply Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to...
In PersonSenior Manager, Regulatory Affairs Advertising and Promotion
- Sanofi
- Cambridge, MA (21 miles from Westford, MA)
- 30+ days ago
- Cambridge, MA (21 miles from Westford, MA)
- 30+ days ago
Job Title: Senior Manager, Regulatory Affairs Advertising and Promotion Location: Morristown, NJ/Cambridge, MA About the Job As the Senior Manager, Regulatory Affairs Advertising and Promotion within...
In PersonManager, Regulatory Affairs, CMC
- Alnylam Pharmaceuticals, Inc.
- Cambridge, MA (21 miles from Westford, MA)
- 30+ days ago
- Cambridge, MA (21 miles from Westford, MA)
- 30+ days ago
The Senior Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for developmental programs....
HybridSenior Manager, Regulatory Affairs NAM
- Straumann
- Andover, MA (14 miles from Westford, MA)
- 45+ days ago
- Andover, MA (14 miles from Westford, MA)
- 45+ days ago
Position Summary: The Senior manager, Regulatory Affairs is responsible for developing and executing regulatory strategies for assigned product portfolios and projects across North America (US and Canada...
In Person- Sanofi
- Cambridge, MA (21 miles from Westford, MA)
- 45+ days ago
- Cambridge, MA (21 miles from Westford, MA)
- 45+ days ago
Job Title: Manager Regulatory Affairs Location: Morristown, NJ Cambridge, MA About the Job Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research....
In PersonDirector, Regulatory Affairs, Advertising and Promotion
- Alkermes
- Waltham, MA (16 miles from Westford, MA)
- 60+ days ago
- Waltham, MA (16 miles from Westford, MA)
- 60+ days ago
Reporting to the Vice President, Regulatory Affairs, Advertising, Promotion & Labeling, the Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound...
HybridAssociate Director Regulatory Affairs Vascular (on-site)
- Abbott
- Westford, MA
- 90+ days ago
- Westford, MA
- 90+ days ago
Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements....
In PersonManager/Senior Manager Regulatory Affairs - Advertising, Labeling, and Promotion
- Beam Therapeutics Inc.
- Cambridge, MA (21 miles from Westford, MA)
- 90+ days ago
- Cambridge, MA (21 miles from Westford, MA)
- 90+ days ago
Company Overview: Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has...
In PersonDirector, Regulatory Affairs Strategy - Oncology
- Regeneron Pharmaceuticals
- Cambridge, MA (21 miles from Westford, MA)
- 90+ days ago
- Cambridge, MA (21 miles from Westford, MA)
- 90+ days ago
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide...
In PersonDemographic Data for Westford, MA
Moving to Westford, MA? Find some basic demographic data about Westford, MA below.
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Salary for Manager of Regulatory Affairs Jobs in Westford, MA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Westford, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Clinical Research
- Biology
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Good Laboratory Practice
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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